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Increasing numbers of heat-sensitive
products, more rigorous regulations: the challenges of temperature-controlled
transport and logistics of healthcare products are at the same time financial,
regulatory, technical and ecological. How has cold chain logistics become a
real challenge for pharmaceutical laboratories? The Evaluate Pharma 2016 Report
addresses this, and here is our analysis.

The rise of biotechs is
generating more and more heat-sensitive healthcare products

The 2000s have been marked by a
period of global economic crisis and the emergence of Generic Laboratories.
Consequently, pharmaceutical laboratories have been forced to review their
strategy and from this point forward focus their research on healthcare products stemming from
biotechnologies.

Although patents are more profitable,
they are longer but their development is also much more expensive. The
pharmaceutical companies are therefore developing innovative treatments
stemming from biotechs, which respond to a growing demand for illnesses such as
cancer or diabetes.

Top 10 therapeutic developments of
pharmaceutical laboratories in 2022.

These medicines, originating from
living cells, are extremely sensitive to variations in temperature, with very
little tolerance to fluctuations.

Consequently, from 2011 to 2017, the number of heat-sensitive healthcare
products increased by 45%: 1 out of 2 medicines on the market is
heat-sensitive.

Market
development of heat-sensitive pharmaceutical products in 2011 and 2017.

Stricter regulations impacting cold
chain logistics

Marie Boned, Quality Distribution Manager &
Pharmacist within the Septodont laboratory, talks to us about the tightening up of regulations with regard to
the cold chain logistics of healthcare products:

“The publication in 2012 of the new GDP (Good
Distribution Practices of medicines) is not without consequences for
temperature-controlled logistics. It requires the implementation of devices
ensuring the temperature control of healthcare products and medicines stored at
+15/+25°C. The logistics of heat-sensitive products is becoming a real headache
for laboratories, which combine the financial-security-regulatory aspect with
increasingly larger volumes.

Simultaneously, laboratories are subject to the
ISO14001 standard which is based on the continuous improvement of environmental
efficiency. The laboratory must act to minimize the damaging effects of its
activities on the environment.”

An inevitable growth of cold chain logistics,
but with new constraints

Thus, the development of biotechs, combined with the
increase of illnesses requiring heat-sensitive treatments and the tightening up
of regulations, has resulted in a clear market
increase of cold chain logistics for medicines and other healthcare products in
volume.

The market for temperature-controlled logistics for
healthcare products could reach 13 billion dollars in 2019, i.e. a 40% increase compared with 2013,
resulting in an average of a 14% cost increase for medicine companies in their
cold chain management expenditure compared with 2017.

Forecasts
of global spending for the biopharmaceutical sector in cold chain logistics for
2019.

In fact, the implementation of cold chain logistics is
far from simple. It is necessary to simultaneously bring together risk management,
cost control, patient safety and regulatory compliance.

So, how to minimize
logistical costs while maintaining temperature security? Two popular responses
include: the circular economy (for air or road transport), or switching to sea
(for air transport). In the following articles, we will expand on these topics
of cost reduction and the environmental impact of cold chain logistics.